Exceed™ Biplanar Expandable Interbody System 11-5344

GUDID 10840642170931

22 mm (L) x 10 mm (W) x 14 mm (H), Lordotic 0°

Spine Wave, Inc.

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• Primary Device ID: 10840642170931
• NIH Device Record Key: f41b52db-6c55-4408-8f3b-b0c149152389
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Exceed™ Biplanar Expandable Interbody System
• Version Model Number: 11-5344
• Catalog Number: 11-5344
• Company DUNS: 067789763
• Company Name: Spine Wave, Inc.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: true
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: true
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com
• Phone: 203-944-9494
• Email: info@spinewave.com

Device Dimensions

• Length: 22 Millimeter
• Width: 10 Millimeter
• Height: 14 Millimeter
• Angle: 0 degree
• Length: 22 Millimeter
• Width: 10 Millimeter
• Height: 14 Millimeter
• Angle: 0 degree
• Length: 22 Millimeter
• Width: 10 Millimeter
• Height: 14 Millimeter
• Angle: 0 degree
• Length: 22 Millimeter
• Width: 10 Millimeter
• Height: 14 Millimeter
• Angle: 0 degree
• Length: 22 Millimeter
• Width: 10 Millimeter
• Height: 14 Millimeter
• Angle: 0 degree
• Length: 22 Millimeter
• Width: 10 Millimeter
• Height: 14 Millimeter
• Angle: 0 degree
• Length: 22 Millimeter
• Width: 10 Millimeter
• Height: 14 Millimeter
• Angle: 0 degree
• Length: 22 Millimeter
• Width: 10 Millimeter
• Height: 14 Millimeter
• Angle: 0 degree
• Length: 22 Millimeter
• Width: 10 Millimeter
• Height: 14 Millimeter
• Angle: 0 degree
• Length: 22 Millimeter
• Width: 10 Millimeter
• Height: 14 Millimeter
• Angle: 0 degree
• Length: 22 Millimeter
• Width: 10 Millimeter
• Height: 14 Millimeter
• Angle: 0 degree
• Length: 22 Millimeter
• Width: 10 Millimeter
• Height: 14 Millimeter
• Angle: 0 degree
• Length: 22 Millimeter
• Width: 10 Millimeter
• Height: 14 Millimeter
• Angle: 0 degree
• Length: 22 Millimeter
• Width: 10 Millimeter
• Height: 14 Millimeter
• Angle: 0 degree
• Length: 22 Millimeter
• Width: 10 Millimeter
• Height: 14 Millimeter
• Angle: 0 degree
• Length: 22 Millimeter
• Width: 10 Millimeter
• Height: 14 Millimeter
• Angle: 0 degree
• Length: 22 Millimeter
• Width: 10 Millimeter
• Height: 14 Millimeter
• Angle: 0 degree
• Length: 22 Millimeter
• Width: 10 Millimeter
• Height: 14 Millimeter
• Angle: 0 degree

Device Identifiers

Device Issuing Agency	Device ID
GS1	10840642170931 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K231275

FDA Product Code

• MAX: Intervertebral Fusion Device With Bone Graft, Lumbar

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: true

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-12-19
• Device Publish Date: 2023-12-11

On-Brand Devices [Exceed™ Biplanar Expandable Interbody System]

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• 10840642171129: 22 mm (L) x 10 mm (W) x 14 mm (H), Lordotic 15°
• 10840642171112: 22 mm (L) x 10 mm (W) x 13 mm (H), Lordotic 15°
• 10840642171105: 22 mm (L) x 10 mm (W) x 12 mm (H), Lordotic 15°
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• 10840642171082: 25 mm (L) x 10 mm (W) x 13 mm (H), Lordotic 8°
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• 10840642171006: 22 mm (L) x 10 mm (W) x 10 mm (H), Lordotic 8°
• 10840642170993: 25 mm (L) x 10 mm (W) x 14 mm (H), Lordotic 0°
• 10840642170986: 25 mm (L) x 10 mm (W) x 13 mm (H), Lordotic 0°
• 10840642170979: 25 mm (L) x 10 mm (W) x 12 mm (H), Lordotic 0°
• 10840642170962: 25 mm (L) x 10 mm (W) x 11 mm (H), Lordotic 0°
• 10840642170955: 25 mm (L) x 10 mm (W) x 10 mm (H), Lordotic 0°
• 10840642170948: 25 mm (L) x 10 mm (W) x 9 mm (H), Lordotic 0°
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• 10840642170924: 22 mm (L) x 10 mm (W) x 13 mm (H), Lordotic 0°
• 10840642170917: 22 mm (L) x 10 mm (W) x 12 mm (H), Lordotic 0°
• 10840642170900: 22 mm (L) x 10 mm (W) x 11 mm (H), Lordotic 0°
• 10840642170894: 22 mm (L) x 10 mm (W) x 10 mm (H), Lordotic 0°
• 10840642170887: 22 mm (L) x 10 mm (W) x 9 mm (H), Lordotic 0°